FR6000 Flowmeter
FDA 510(k) K884973 · Key Instruments
510(k) numberK884973
Submission
- Device name
- FR6000 Flowmeter
- Applicant
- Key Instruments
Trevose, PA, US - Received
- November 30, 1988
- Decision date
- January 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAX – Flowmeter, Tube, Thorpe, Back-Pressure Compensated
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2340
- Specialty
- Anesthesiology
Other 510(k)s with product code CAX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923781 | MXR-2000 FlowmeterCAX · Traditional | Porter Instrument Co., Inc. | 06/10/1993SE |
| K910316 | Ohmeda - Low Flow FlowmeterCAX · Traditional | Ohmeda Medical | 04/12/1991SE |
| K872718 | Series D FlowmeterCAX · Traditional | Puritan Bennett Corp. | 08/05/1987SE |
| K871452 | Classic (TM) 200 Oxygen FlowmeterCAX · Traditional | The Timeter Group | 06/22/1987SE |
| K862797 | Airco 2000 Series FlowmetersCAX · Traditional | Airco, Inc. | 08/08/1986SE |
| K854067 | Select FlowmeterCAX · Traditional | Precision Medical, Inc. | 10/29/1985SE |
| K851288 | Oxygen Delivery Measuring DeviceCAX · Traditional | Bar-Dix, Inc. | 09/03/1985SE |
| K850559 | Pressure Relief AdaptorCAX · Traditional | Precision Medical, Inc. | 04/25/1985SE |
| K850560 | Flowmeter, Backpressure Compensated, Thorpe TubeCAX · Traditional | Precision Medical, Inc. | 04/17/1985SE |
| K834260 | RECON-2 Flow ControllerCAX · Traditional | Precision Metering, Inc. | 01/10/1984SE |
Questions and answers
When was FR6000 Flowmeter cleared by the FDA?
FR6000 Flowmeter (K884973) received a 510(k) decision of Substantially Equivalent on January 17, 1989, 48 days after the submission was received.
What is the product code of K884973?
The FDA product code is CAX – Flowmeter, Tube, Thorpe, Back-Pressure Compensated, a Class I (low risk) device regulated under 21 CFR 868.2340.